Medical Device Classification EU MDR
Determination of the Medical Device Classification and the corresponding classification rule is the first step in the EU CE Marking process. Based on the class and the rule of the device, the technical file and the Notified Body application can be filed.
According to the EU MDR 2017/745, Article 51, medical devices are classified into I, IIa, IIb, and III, considering their intended purposes and their inherent risks. The risk is incremental from class I to class III. EU Medical Device Directive (MDD) and EU Medical Device Regulation (MDR) both use a rule-based classification pattern for medical devices. in the new MDR, there are now 22 rules in Annex VIII.
Medical Device Classification with Examples!
Class 1 - Low Risk
Type of Certification : Self Certification / Self Declaration
Class 1s Low Risk (Sterile)
Examples : Personal protection kits, Sterile Urine Bags, etc.
Type of Certification : Notified Body
Class 1m Low Risk (Measuring Body attributes)
Examples : Stethoscopes, Weighing Balance
Type of Certification : Notified Body
Class 1r Low Risk ( Reused Device)
Examples : Surgical forceps ( All type of SS/Tit surgical equipment’s sterilized and reused by hospitals)
Type of Certification : Notified Body
Class IIa - Medium Risk
Type of Certification : Notified Body
Class IIb - Medium to High Risk
Type of Certification : Notified Body
Class III - High Risk
Type of Certification : Notified Body
Medical Device Classification Rules!
As per Annex VIII of the MDR, the Classification Rules are as follows:
- Rules 1- 4: Non-invasive Devices
- Rules 5 – 8: Invasive Devices
- Rules 9 – 13: Active Devices
- Rules 14 – 22: Special Rules
I3CGLOBAL Scope
I3CGLOBAL successfully completed 300+ CE Certifications worldwide by supporting manufactures with device classification of simple and complex device technologies for faster NB approval. We have offices in India, Europe, and the USA to help with classification and technical documentation.